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AFFINIS heavy body System 360 Starter Kit, 1 x 380ml
EUDAMEDClass IIa (EU MDR)
Ref 6485Model Impression Material
by Dent4You AG
Identity
- Trade Name
- AFFINIS heavy body System 360 Starter Kit, 1 x 380ml EUDAMED
- Model / Reference
- Impression Material EUDAMED6485 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630243635252 EUDAMED
- Basic UDI-DI
- 76303929ASIL190613K EUDAMED
- EMDN Code
- Q01020104 DENTAL IMPRESSION SILICONES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Silicone dental impression material
AFFINIS heavy body System 360 Starter Kit, 1 x 380ml by Dent4You AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76303929ASIL190613K | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dent4You AG
- EUDAMED SRN
- CH-MF-000028926
- Authorised Representative
- Dent4you GmbH DE-AR-000006093
Sources (1)
- EUDAMED 1341cf5d-ff0c-48b2-bfa5-30152badbff5 61 fields · synced Jun 18, 2026